# K200910: BOSS Balloon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Marblehead Medical
- Decided: May 2, 2020 after 26 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010954 (2001). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153729: 8F FlowGate2 Balloon Guide Catheter, Concentric Medical (2016) Summary page 4.
- K111380: Neuron Max System, Penumbra, Inc. (2011) Summary page 4.

## Most influential descendants
- K203840: BOSS 8F Balloon Guide Catheter (2021), 0 descendants of its own

## Indications for use
The BOSS Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

Source page: https://510kreport.com/device/K200910
Methodology: https://510kreport.com/methodology